Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Exemestane
Actavis Group PTC ehf
L02BG; L02BG06
Exemestane
25 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Aromatase inhibitors; exemestane
Marketed
2010-10-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EXEMESTANE ACTAVIS 25 MG FILM-COATED TABLETS exemestane READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Exemestane Actavis is and what it is used for 2. What you need to know before you take Exemestane Actavis 3. How to take Exemestane Actavis 4. Possible side effects 5. How to store Exemestane Actavis 6. Contents of the pack and other information 1. WHAT EXEMESTANE ACTAVIS IS AND WHAT IT IS USED FOR Exemestane Actavis belongs to a group of medicines known as aromatase inhibitors. These medicines interfere with a substance called aromatase, which is needed to make the female sex hormones, oestrogens, especially in postmenopausal women. Reduction in oestrogen levels in the body is a way of treating hormone dependent breast cancer. Exemestane Actavis is used to treat hormone dependent early breast cancer in postmenopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen. Exemestane Actavis is also used to treat hormone dependent advanced breast cancer in postmenopausal women when a different hormonal drug treatment has not worked well enough. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EXEMESTANE ACTAVIS DO NOT TAKE EXEMESTANE ACTAVIS - if you are or have previously been allergic to exemestane (the active ingredient in Exemestane Actavis) or any of the other ingredients of this medicine (listed in section 6). - if you have NOT already been through ‘the menopause’, i.e. you are still having your monthly pe Aqra d-dokument sħiħ
Health Products Regulatory Authority 19 June 2020 CRN009MR7 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Exemestane Actavis 25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg exemestane. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Exemestane 25 mg film-coated tablets are white, round, lenticular, with uniform appearance and intact edges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Exemestane Actavis is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer (EBC), following 2 ‑ 3 years of initial adjuvant tamoxifen therapy. Exemestane Actavis is indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy. Efficacy has not been demonstrated in patients with oestrogen receptor negative status. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult and elderly patients_ The recommended dose of Exemestane Actavis is one 25 mg tablet to be taken once daily, preferably after a meal. In patients with early breast cancer, treatment with Exemestane Actavis should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by Exemestane Actavis), or earlier if tumour relapse occurs. In patients with advanced breast cancer, treatment with Exemestane Actavis should continue until tumour progression is evident. No dose adjustments are required for patients with hepatic or renal insufficiency (see section 5.2). _Paediatric population_ Exemestane Actavis is not recommended for use in children. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In pre-menopausal women and in pregnant or lactating women. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Exemestane should not be administered to women w Aqra d-dokument sħiħ